NEOSTIGMINE METHYLSULFATE

Product NDC: 0404-9925
11-digit product format: 004049925
Labeler code: 0404
Product ID: 0404-9925_84fbf39b-c286-4c2e-abb2-7639324c4602
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: neostigmine methylsulfate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA209933
Marketing category: ANDA
Marketing start: 2022-01-13
Marketing end: 0000-00-00
Substance: NEOSTIGMINE METHYLSULFATE
Active strength: 1 mg/mL
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0404-9925		D	Discontinued by firm		2026-08-11
excluded package	package	0404-9925	0404-9925-10	D	Discontinued by firm		2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209933-001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-09-25
A209933-002	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2017-09-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209933-001	AP
A209933-002	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209933-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209933-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-09-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209933-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209933-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209933-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209933-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209933-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209933-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209933-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209933-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209933-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209933-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209933-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209933-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209933-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209933-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209933-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209933-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209933-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209933-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209933-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209933-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209933-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209933-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209933-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209933-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209933-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209933-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209933-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209933-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209933-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209933-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209933-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209933-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209933-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209933-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209933-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209933-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209933-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209933-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209933-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209933-002	AP	1	`782e0a99824c…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9925	NEOSTIGMINE METHYLSULFATE INJECTION [HENRY SCHEIN, INC.]	5	Legacy NDC	20250112_5f540e86-2a56-4cc0-8f69-64f051830a3d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	HF Acquisition Co LLC, DBA HealthFirst	c4be8467-7b7e-551d-e053-2995a90a3045	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209933 application number: ANDA209933
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	Amphastar Pharmaceuticals, Inc.	e47a4a4c-0e7c-40b6-9950-5b3adadcac22	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209933 application number: ANDA209933
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	Medical Purchasing Solutions, LLC	7978e3c0-6ee3-6db5-e053-2991aa0a2d33	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209933 application number: ANDA209933

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98IMH7M386	NEOSTIGMINE METHYLSULFATE	51-60-5	NEOSTIGMINE METHYLSULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9925-10	00404992510	1 VIAL, MULTI-DOSE in 1 BAG (0404-9925-10) > 10 mL in 1 VIAL, MULTI-DOSE	2022-01-13	0000-00-00	No	No	Current